Prescription medicine
Meclofenamate First approved as Meclomen
Meclofenamate (Meclomen) is a prescription medicine with an FDA approval on record since 1980. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the meclofenamate FDA label on DailyMed (effective April 15, 2026, Mylan Pharmaceuticals Inc.); the NDA 18006 record on Drugs@FDA; every meclofenamate label on DailyMed.
Highlights of the record
FDA label of April 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS ).
Meclofenamate sodium capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS ). Gastrointestinal Risk
NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. (See WARNINGS ).
Used for
From the label: indications and usageCarefully consider the potential benefits and risks of meclofenamate sodium capsules and other treatment options before deciding to use meclofenamate sodium capsules.
Forms and strengths
- 50 mg
- 100 mg
Capsule.
On the market
- Earliest approval on file
- June 25, 1980 Meclomen, Parke Davis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first September 3, 1986; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 55 through July 30, 2026
What is meclofenamate used for?
From the label: indications and usageCarefully consider the potential benefits and risks of meclofenamate sodium capsules and other treatment options before deciding to use meclofenamate sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Meclofenamate sodium capsules are indicated:
For reduction of fever in adults
For relief of mild to moderate pain in adults
For relief of signs and symptoms of juvenile arthritis.
For relief of the signs and symptoms of rheumatoid arthritis
For relief of the signs and symptoms of osteoarthritis.
For treatment of primary dysmenorrhea. […]
Conditions named in the indications of meclofenamate's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Meclofenamate Sodium), Mylan Pharmaceuticals Inc., effective April 15, 2026 (SPL set 96f19af4-de8f-4fd7-90d8-55fe6ebdd81d), via openFDA; the full label on DailyMed
What does the patient leaflet for meclofenamate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: o with increasing doses of NSAIDs o with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: o anytime during use o without warning symptoms o that may cause death The risk of getting an ulcer or bleeding increases with: o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs o taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” o increasing doses of NSAIDs o longer use of NSAIDs o smoking o drinking alcohol o older age o poor health o advanced liver disease o bleeding problems NSAIDs should only be used: o exactly as prescribed o at the lowest dose possible for your treatment o for the shortest time needed
Source: FDA drug label (Meclofenamate Sodium), Mylan Pharmaceuticals Inc., effective April 15, 2026 (SPL set 96f19af4-de8f-4fd7-90d8-55fe6ebdd81d), via openFDA; the full label on DailyMed
Is there a generic for meclofenamate (Meclomen)?
The FDA approved the first generic meclofenamate on September 3, 1986. 6 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists meclofenamate from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1980 earliest approval on file
- 1986 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the meclofenamate label say about other medicines?
The meclofenamate label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name meclofenamate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | contraindications | Meclofenamate sodium capsules should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. |
| Furosemide | drug interactions | Furosemide Clinical studies, as well as post-marketing observations, have shown that meclofenamate sodium can reduce the natriuretic effect-of furosemide and thiazides in some patients. |
| Lithium | drug interactions | Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. |
| Methotrexate | drug interactions | Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. |
| Warfarin | drug interactions | Warfarin The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. |
Source: FDA drug label (Meclofenamate Sodium), Mylan Pharmaceuticals Inc., effective April 15, 2026 (SPL set 96f19af4-de8f-4fd7-90d8-55fe6ebdd81d), via openFDA; the full label on DailyMed
What do FAERS reports show for meclofenamate?
The FDA Adverse Event Reporting System holds 55 reports that list meclofenamate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 17 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as meclofenamate?
5 other medicines are given the same way (oral) and in the same FDA class as meclofenamate or labeled mainly for the same use (fever), the same class first. Fever lists all 8 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ibuprofen | Pain, Osteoarthritis, Rheumatoid arthritis, Fever | 273 labelers | $0.0573 per tablet 800 mg tablet | No current entry |
| Acetaminophen | Pain, Fever | 79 labelers | $0.0339 per unit 500 mg caplet | No current entry |
| Naproxen | Pain, Osteoarthritis, Rheumatoid arthritis, Fever | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Aspirin | Pain, Fever | none listed | $0.0142 per tablet 81 mg tablet | A presentation being discontinued |
| Dextromethorphan and guaifenesin and naproxen | Fever | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Meclofenamate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other